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Last Updated: October 20, 2019

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Zolpidem tartrate - Generic Drug Details

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What are the generic drug sources for zolpidem tartrate and what is the scope of patent protection?

Zolpidem tartrate is the generic ingredient in seven branded drugs marketed by Aytu, Sanofi Aventis Us, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex Inc, Lupin Ltd, Sandoz, Sun Pharm, Synthon Pharms, Biovail Labs Intl, Acme Labs, Aurobindo Pharma, Cipla Ltd, Dr Reddys Labs Ltd, Hikma, Invagen Pharms, Mylan, Mylan Pharms Inc, Sandoz Inc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Vintage, Watson Labs, Wockhardt, Yung Shin Pharm, Mylan Speciality Lp, Purdue Pharma, Dr Reddys, Novel Labs Inc, Par Form, and Par Pharm Inc, and is included in forty NDAs. There are ten patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zolpidem tartrate has two hundred and fifty patent family members in thirty-six countries.

There are thirty-three drug master file entries for zolpidem tartrate. Fifty-four suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for zolpidem tartrate

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Drug Sales Revenue Trends for zolpidem tartrate

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Recent Clinical Trials for zolpidem tartrate

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SponsorPhase
National Institute on Aging (NIA)Phase 4
National Institutes of Health (NIH)Phase 4
University of PennsylvaniaPhase 4

See all zolpidem tartrate clinical trials

Recent Litigation for zolpidem tartrate

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District Court Litigation
Case NameDate
Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-15
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13
SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC.2015-01-16

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Generic filers with tentative approvals for ZOLPIDEM TARTRATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MGTABLET;ORAL
  Start Trial  Start Trial5MGTABLET;ORAL
  Start Trial  Start Trial10MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for zolpidem tartrate

US Patents and Regulatory Information for zolpidem tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 090107-002 Jul 1, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077288-001 Apr 23, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Par Form ZOLPIDEM TARTRATE zolpidem tartrate TABLET;SUBLINGUAL 201509-002 Aug 1, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078016-001 Apr 23, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for zolpidem tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us AMBIEN zolpidem tartrate TABLET;ORAL 019908-002 Dec 16, 1992   Start Trial   Start Trial
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009   Start Trial   Start Trial
Aytu ZOLPIMIST zolpidem tartrate SPRAY, METERED;ORAL 022196-001 Dec 19, 2008   Start Trial   Start Trial
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for zolpidem tartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 C300714 Netherlands   Start Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132 122015000006 Germany   Start Trial PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2236132 484 Finland   Start Trial
2236132 92636 Luxembourg   Start Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Harvard Business School
Dow
Express Scripts
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.